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USP Class VI: New Approach to Polymer Safety in Medical Devices
by
Gabriele Pincitore
|
24/03/2026
24/03/2026
|
Blog
,
Medical
For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...
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Novel Food in Ingredients and Food Supplements: Key Differences
by
Gabriele Pincitore
|
17/03/2026
17/03/2026
|
Blog
,
Food
Did you know that in the EU an ingredient can be classified as a Novel...
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Regulation EU 2026/405: New Detergents and Surfactants Compliance
by
Gabriele Pincitore
|
10/03/2026
10/03/2026
|
Blog
,
Chemical
Regulation (EU) 2026/405 is the new European Union regulation on detergents and surfactants, published in...
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February Regulatory Updates
by
Gabriele Pincitore
|
03/03/2026
02/04/2026
|
Agro
,
Blog
,
Chemical
Biocides: BPC approves Ethanol use for disinfectants and hand sanitizers On February 24 in Helsinki,...
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Permitted Daily Exposure within EMA and ICH Framework
by
Gabriele Pincitore
|
24/02/2026
26/02/2026
|
Blog
,
Pharma
Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
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EUDAMED is Now Mandatory: What has changed since May 2026
by
Gabriele Pincitore
|
17/02/2026
23/06/2026
|
Blog
,
Medical
The European Database on Medical Devices, a key element of the European Union’s regulatory framework...
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PFAS: Compliance of the “Forever Chemicals”
by
Gabriele Pincitore
|
10/02/2026
10/02/2026
|
Blog
,
Chemical
What are PFAS? The large family of synthetic substances is characterized by the presence of...
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January Regulatory Updates
by
Gabriele Pincitore
|
02/02/2026
06/02/2026
|
Blog
,
Chemical
,
Medical
,
Regulatory Updates
Medical Devices: FDA’s SaMD Clinical Evaluation Guidance withdrawn The FDA revised its guidelines in 2026...
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EFSA’s New Guidance on Food Additives: What You Need to Know
by
Gabriele Pincitore
|
27/01/2026
05/02/2026
|
Blog
,
Food
In the European Union, food additives can be used in food and beverages only if...
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ISO 18969 Clinical Evaluation: Key Changes to Know
by
Gabriele Pincitore
|
20/01/2026
05/02/2026
|
Blog
,
Medical
Clinical evaluation remains one of the most critical and challenging elements of medical device compliance....
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